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Avantor, a Global Fortune 500 company, is looking for a dedicated Quality Inspector to optimize our VWR Chemical organization. This Solon, OH role is full-time, working on-site Monday through Friday 2- 10:30 PM. The Solon location specializes in quality chemical down packing of dry chemicals and liquid solutions; finished packaging; in- house testing as well as contract medical device manufacturing.
Job Responsibility:
Comply with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality
Ensuring customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements
Ensuring technicians understand and follow documented Avantor/ VWR procedures and GMP / GDocP requirements
Ensure customer requirements are met
Verify adherence to policies, procedures, and work instructions
Ensure documentation and physical product segregation and containment of non-conforming material identified during the production process
Review production documentation for accuracy, completeness, and GDocP compliance
Assist in correcting order issues and ensure actions are appropriate
Communicate issues / concerns to area owner and direct manager
Ensure that the work area is in a state of “audit readiness”
Perform inspection tasks by following established work instructions and procedures, by using required tools, methods and equipment, to determine acceptability of product, components, and documentation
Perform pre-fill, in-process, and final inspections with the aid of documented work instructions
Provides first response in QA oversite to production activities
Give immediate go/no-go decisions for issues on the production floor, especially related to time-restricted product
Stop production when a critical non-conformance (NCM) is observed and follow appropriate NCM procedures
Document non-conformances following applicable Avantor/VWR procedures and work instructions
Documenting quality production issues discovered during inspection
Utilize problem solving tools such as 5M+E, 5 Why’s, or other root cause analysis tools / methods to identify and permanently resolve issues
Adheres to Avantor/ VWR QMS policies
Walk the floor to observe, train, and facilitate / support change
Performing other duties as assigned
Requirements:
High School / GED
3+ years relevant experience
Experience in a Quality Assurance role within the medical device, biotech, food, or pharmaceutical industry
Experience with current Good Manufacturing and Documentation practices (cGMP, cGDocP)
Multi-tasking and prioritizing efficiently
Knowledge of ISO 9001, ISO 13485, 21 CFR 820 and 21 CFR 11 standards
Experience conducting root cause analysis as it relates to non‑conforming material investigations